Microbial ColonizationFIBNCT04159259
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)
A study testing Low fiber diet and Pea Fiber Bar in people with Microbial Colonization, run by Washington University School of Medicine at 1 site in United States.
Trial summary
All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Low fiber diet and Pea Fiber Bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25.0-35.0 kg/m²
- Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance
Who cannot join
- Previous bariatric surgery
- Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or cardiovascular disease)
- Cancer or cancer that has been in remission for less than 5 years
- Major psychiatric illness
- Inflammatory gastrointestinal disease
- Pregnant or lactating women
Show all 12Show fewer
- Use of medications that are known to affect the study outcome measures
- Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
- Bowel movements less than 3 times per week
- Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
- Persons that are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome
All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.
- Conditions
- Microbial Colonization
- Being tested
- Low fiber diet, Pea Fiber Bar
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fiber dietOther
Participants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49)
Pea Fiber BarOther
Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35
Low fiber dietOther
Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.
| Study group | Role | What they receive |
|---|---|---|
| Diet intervention | Experimental | All participants will stay weight stable while undergoing 3 phases of a dietary intervention Receives: Other: Low fiber diet; Other: Pea Fiber Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
Blood will be drawn for the complete metabolic panel and lipid panel
Measured: At screening, day 14, day 35, and day 49
Changes to the gut microbiota as assessed by established culture independent methods, as well as LC-QTOF Mass-Spectometry (MS) and LC-QQQ MS and GC-MS
Frequent stool samples will be collected throughout the entire study
Measured: stool samples will be collected from the screening visit through the final day of the 49-day intervention
Changes in urine proteomes and metabolomes as assessed by liquid chromatography
First morning urine samples will be collected periodically throughout the study
Measured: Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study
Changes in plasma proteomes and metabolomes as assessed by liquid chromatography
fasting blood draws will be collected periodically throughout the study
Measured: Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study
Change in hemoglobin A1c (HbA1c) in response to the dietary intervention
Blood will be drawn for the HbA1c
Measured: At screening, day 14, day 35, and day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start13 Feb 2019
- Primary completion30 Aug 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159259
- Sponsor's protocol ID
- 201812063
- Acronym
- FIB
- Status last verified
- Dec 2024
- First submitted
- 21 Mar 2019
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome
- ClinicalTrials.gov ID
- NCT04159259
- Acronym / sponsor ID
- FIB / 201812063
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet intervention | Experimental | Other: Low fiber diet, Other: Pea Fiber BarAll participants will stay weight stable while undergoing 3 phases of a dietary intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 25.0-35.0 kg/m²
- Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance
Key exclusion criteria (12 listed)
- Previous bariatric surgery
- Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or cardiovascular disease)
- Cancer or cancer that has been in remission for less than 5 years
- Major psychiatric illness
- Inflammatory gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fiber dietParticipants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49) | Other | Diet intervention |
| Pea Fiber BarParticipants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35 | Other | Diet intervention |
| Low fiber dietParticipants will return to the low fiber diet for days 36-49- this phase is the same as phase 1. | Other | Diet intervention |
Primary outcome
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
Time frame: At screening, day 14, day 35, and day 49
Blood will be drawn for the complete metabolic panel and lipid panel
Changes to the gut microbiota as assessed by established culture independent methods, as well as LC-QTOF Mass-Spectometry (MS) and LC-QQQ MS and GC-MS
Time frame: stool samples will be collected from the screening visit through the final day of the 49-day intervention
Frequent stool samples will be collected throughout the entire study
Changes in urine proteomes and metabolomes as assessed by liquid chromatography
Time frame: Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study
First morning urine samples will be collected periodically throughout the study
Changes in plasma proteomes and metabolomes as assessed by liquid chromatography
Time frame: Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study
fasting blood draws will be collected periodically throughout the study
Change in hemoglobin A1c (HbA1c) in response to the dietary intervention
Time frame: At screening, day 14, day 35, and day 49
Blood will be drawn for the HbA1c
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fiber diet and Pea Fiber Bar in people with Microbial Colonization, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel. (time frame: At screening, day 14, day 35, and day 49). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.